CN111281544B

CN111281544B - Automatic guiding robot system for in-vivo medical instrument and automatic guiding method thereof

Info

Publication number: CN111281544B
Application number: CN202010120178.5A
Authority: CN
Inventors: 宋璐; 卫亚博; 冯艳平; 宋燕燕; 孙艳敏
Original assignee: Shaanxi University of Chinese Medicine
Current assignee: Shaanxi University of Chinese Medicine
Priority date: 2020-02-26
Filing date: 2020-02-26
Publication date: 2023-05-12
Anticipated expiration: 2040-02-26
Also published as: CN111281544A

Abstract

The invention provides an in-vivo medical instrument automatic guiding robot system, comprising: the driver is in driving connection with the flexible instrument and is used for driving the flexible instrument to generate linear motion and rotary motion in the anatomical structure; a flexible instrument for insertion into a target site of an anatomical structure; a tracking module for obtaining a position of the flexible instrument within the patient anatomy; and the computer module is used for outputting a control instruction to the driver. Simultaneously, an automatic guiding method based on the automatic guiding robot system for the medical instruments in the body is provided. The invention obviously reduces the X-ray irradiation to patients and doctors; minimizing friction between the flexible instrument and the robotic component; the overall size of the robotic system is reduced; the production cost is reduced; shortens the duration of clinical procedures and enables accurate guidance of in-vivo medical devices to a target site.

Description

Automatic guiding robot system for in-vivo medical instrument and automatic guiding method thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to an in-vivo medical instrument automatic guiding robot system and an automatic guiding method thereof.

Background

Medical interventions such as endovascular surgery, lung nodule biopsies or any other surgery requiring catheter insertion in the human body require the use of CT and fluoroscopic imaging guidance, which can lead to potentially unsafe factors for patients and doctors exposed to X-rays for long periods of time. Lung cancer is the most common cancer worldwide, with new cases diagnosed more than 200 tens of thousands each year. Fortunately, the likelihood of survival is greatly increased if found early. If diagnosed at stage I, survival rate >75% within 5 years, whereas diagnosed at stage IV, survival rate is only 1%. Early diagnosis requires the discovery and sampling (biopsy) of small nodules located in the lung parenchyma and mainly around the bronchi. Currently, patients are often prompted for further diagnosis after they receive pulmonary radiological imaging to identify suspicious nodules. In bronchoscopy, a camera is inserted into the airway, but due to the large volume it cannot reach near malignant lung nodules in the small airway. For biopsy, the bronchoscope must be advanced blindly through a sharp biopsy needle or forceps in the general direction of the nodular lung tissue. To improve the accuracy of the procedure, close-up x-ray (fluoroscopy) examinations are typically performed in real-time, exposing the patient and the physician to harmful radiation.

Computer-aided techniques and medical robotics offer viable solutions, but are currently not optimal. In the existing computer-aided technology and medical robot technology, when interventional therapy is performed, an image device is generally adopted to monitor the position of a catheter in a patient, and then an operator adjusts the direction and the control speed in real time according to subjective judgment, so that the following problems generally exist: the technical costs and conditions of use are high, the use is complex, the aiming accuracy is low, the system size is large, the proper instruments and specific guides are lacking, friction between the catheter-like instruments and the robotic components is increased, and the patient and doctor still need to be exposed to X-rays.

No description or report of similar technology is found at present, and similar data at home and abroad are not collected.

Disclosure of Invention

The invention aims at the defects in the prior art and provides an automatic guiding robot system for medical instruments in a body and an automatic guiding method thereof. The system and method enable the flexible instrument to be rotationally advanced while being inserted into the anatomy by configuring the insertion device and the rotation device to position the flexible instrument to a target location of the anatomy by a tracking sensor positioned at the tip of the flexible instrument.

The invention is realized by the following technical scheme.

According to one aspect of the present invention, there is provided an in-vivo medical device automatic guidance robot system, comprising:

a driver; is in driving connection with the flexible instrument and is used for driving the flexible instrument to generate linear motion and rotary motion in the anatomical structure;

a tracking module; for obtaining a position of the flexible instrument within the patient's anatomy;

and a computer module: for outputting control instructions to the driver.

Preferably, the driver comprises a lead, an insertion device, a rotation device, a driver controller, and a multi-joint arm; wherein:

the lead runs along the flexible instrument and is respectively connected with the flexible instrument and the tracking module, and is used for connecting the flexible instrument to the tracking module;

the insertion device is used for realizing the linear motion of the flexible instrument;

the rotating device is used for realizing the rotating motion of the flexible instrument;

the driver controller is respectively connected with the inserting device and the rotating device in a control way;

the multi-joint arm is used for supporting and fixing the insertion device and the rotating device.

Preferably, the insertion device comprises: the device comprises a winding drum, an inserting motor, a first gear, a second gear, a winding drum first shell, a winding drum second shell, an inserting device bracket and an inserting device shell; wherein:

The flexible instrument is detachably coiled on the winding drum; the insertion motor is in driving connection with the winding drum through the second gear and the first gear in sequence and is used for driving the winding drum to rotate so as to drive the flexible instrument to be unfolded and pass through the opening on the first shell of the winding drum, and the flexible instrument is inserted into the anatomical structure to realize linear movement of the flexible instrument; changing the rotational direction of the reel to retract the flexible instrument from the anatomy onto the reel;

the reel and the flexible instrument are packaged in a first reel housing and a second reel housing to form a detachable reel assembly; the first gear is arranged on the outer side of the second shell of the winding drum; the second gear is meshed with the first gear; the first gear, the second gear and the reel assembly are respectively arranged at corresponding positions on the insertion device bracket, and a rotary ball bearing is arranged between the reel assembly and the insertion device bracket; the insertion device housing is disposed outside the insertion device holder.

Preferably, the spool is provided with a helical channel on which the flexible instrument is coiled.

Preferably, the rotating device includes: a rotating device bracket, a rotating motor mounted on the rotating device bracket, a first bevel gear and a second bevel gear; the rotary motor is in driving connection with a first bevel gear, and the first bevel gear is meshed with a second bevel gear; the second bevel gear is connected with an inserting device bracket of the inserting device through an inserting ball bearing;

The rotating motor drives the first bevel gear to rotate, the first bevel gear drives the second bevel gear to rotate, and the second bevel gear drives the whole inserting device to rotate, so that the flexible instrument is driven to do rotary motion around the axis of the flexible instrument.

Preferably, the multi-joint arm is disposed at a bottom end of a rotating device bracket of the rotating device, and includes: a fixed part for connection to an operating table, and an angularly adjustable fixed part for fixing the insertion device and the rotation device at different angles.

Preferably, the driver controller controls the insertion motor of the insertion device and the rotating motor of the rotating device to work according to the instruction of the computer module, and the linear movement and the rotating movement of the flexible instrument entering the anatomical structure are realized under the driving of the motor.

Preferably, the driver controller receives information from the computer module and controls the motor based on the information to control movement of the flexible instrument.

Preferably, the driver controller controls the motor through an IEEE/LabVIEW interface.

Preferably, the flexible instrument comprises one or more lumens, an instrument tip disposed at the distal end of the lumens, and a tip sensor disposed at the instrument tip; the instrument tip guides the flexible instrument through the anatomy, and the tip sensor is connected to a lead running along the flexible instrument, through which the tip sensor is connected to the tracking module.

Preferably, the tracking module adopts an electromagnetic tracking system, and comprises a magnetic field generator, a main unit and one or more electromagnetic tracking sensors; the magnetic field generator is arranged in the vicinity of the patient; the main unit is connected with an electromagnetic tracking sensor placed at a corresponding position of a patient through a wire; the tip sensor is connected with the main unit through a wire; the main unit is connected with the computer module through a wire; wherein:

the magnetic field generator is used for generating an alternating magnetic field;

the electromagnetic tracking sensor is used for inducing an alternating magnetic field generated by the magnetic field generator and transmitting data of induction signals to the main unit;

the main unit receives data from the electromagnetic tracking sensor, processes the data, sends the processed data to the computer module, and calculates specific position information by the computer module;

the position of the tip sensor is determined by a coordinate system provided on an electromagnetic tracking sensor, which forms a tracking mark.

Preferably, the computer module comprises: the system comprises a medical program planning module, a navigation module, a man-machine interaction module and an imaging module; wherein:

The imaging module is used for receiving one or more CT and/or MRI images corresponding to the anatomical structure, compressing the images and receiving one or more tracking mark signals, and configuring the images as three-dimensional map images of the anatomical structure, wherein the mapping points of the target position on the map are represented by a coordinate system established on an electromagnetic tracking sensor;

the medical procedure planning module is used for identifying target positions on one or more images corresponding to the anatomical structure;

the navigation module is used for creating a traveling path of the flexible instrument according to the entry point and the target position on the three-dimensional map;

the man-machine interaction module is used for generating a control instruction to a driver controller of the driver so as to control the movement of the flexible instrument.

According to another aspect of the present invention, there is provided an automatic guidance method implemented based on the automatic guidance robot system for in-vivo medical devices of any one or any plurality of the above, comprising:

s1, a computer module receives information from a tip sensor, creates an access path, namely a travel path, and calculates the position of the tip sensor on the travel path; the position of the tip sensor is used for calculating the expected path section and the linear motion and the rotary motion to be realized by the flexible instrument driven by a corresponding group of motors;

S2, calculating the expected path section and the linear motion and the rotary motion to be realized by the flexible instrument driven by a group of motors according to the position of the tip sensor obtained in the S1;

s3, generating a control instruction for a driver according to the expected path section obtained in the S2 and the linear motion and the rotary motion to be realized by the flexible instrument, and controlling the flexible instrument to move from the current position to the target point along the expected path corresponding to the flexible instrument;

s4, repeating the steps S1 to S3 until the flexible instrument reaches the target point.

Preferably, in S1: the positions of the entry point and the target point in the anatomical structure are identified by a medical procedure planning module in the computer module, and a travel path is calculated and created from the positions of the entry point and the target point in a three-dimensional map image configured as the anatomical structure using a navigation module in the computer module.

Preferably, in S2: the computer module receives information from the tip sensor of the flexible instrument, calculates the position of the tip sensor on the travelling path, and calculates the linear motion and the rotary motion to be realized by the flexible instrument driven by the expected path section and a corresponding group of motors according to the position information and the length of the expected path section set by the program.

Preferably, in S3: and generating a control instruction for the driver according to the obtained expected path section and the linear motion and the rotary motion to be realized by the flexible instrument, and controlling the flexible instrument to move from the current position to the target point along the expected path section corresponding to the flexible instrument.

The automatic guiding robot system for the in-vivo medical instruments and the automatic guiding method thereof provided by the invention are provided with an automatic guiding and inserting flexible instrument driving device, and can be used for guiding flexible instruments such as medical catheters, endoscopes, flexible surgical instruments (such as guide wires), radio frequency or cryoablation catheters and the like, and combined flexible instruments such as biopsy needles, sutures, forceps with small diameters and customized clamps, scissors, surgical knives and the like which enter through the lumen of the catheters.

The invention provides an in-vivo medical instrument automatic guiding robot system and an automatic guiding method thereof, wherein the in-vivo medical instrument automatic guiding robot system comprises a flexible instrument which is inserted into an anatomical structure or is directed to the anatomical structure in a clinging manner. The flexible instrument may include a tip sensor proximate the tip. Also included are insertion means for driving the flexible instrument into or near the anatomy via a motor and rotation means which can be driven by the motor to rotate the entire insertion means to guide the flexible instrument into or near the anatomy. A driver controller is also included that controls movement of the flexible instrument via the motor. Also included is a tracking module that determines the position of the tip sensor via one or more tracking markers, and a computer module that can receive information from the tracking module and create a position of the tracking sensor in the anatomy. The driver controller may receive movement information about the flexible instrument from the computer module and control the flexible instrument into the anatomy by controlling the motor.

The present invention provides an in-vivo medical device automatic guidance robot system and an automatic guidance method thereof, which are capable of performing CT/MRI imaging on a patient, such as capturing anatomical structures and markers, by attaching tracking markers of a tracking module to the patient's body. Rendering the 3D model or anatomical structure in a reference frame to which the tracking markers are attached, and loading the 3D model onto a computer module, creating an access path (e.g., along an artery, trachea, esophagus) and a target point on the 3D model or anatomical structure by the computer module.

Compared with the prior art, the invention has the following beneficial effects:

the automatic guiding robot system and the automatic guiding method for the in-vivo medical instrument provided by the invention obviously reduce the X-ray irradiation to patients and doctors; minimizing friction between the flexible instrument and the robotic component; the overall size of the robotic system is reduced; the production cost is reduced; shortens the duration of clinical procedures and enables accurate guidance of in-vivo medical devices to a target site.

Drawings

Other features, objects and advantages of the present invention will become more apparent upon reading of the detailed description of non-limiting embodiments, given with reference to the accompanying drawings in which:

Fig. 1 is a schematic diagram of an application of an in-vivo medical device automatic guidance robot system according to an embodiment of the present invention.

Fig. 2 is a schematic diagram of a catheter driver according to an embodiment of the present invention.

Fig. 3 is an exploded view of a catheter driver according to an embodiment of the present invention.

Fig. 4 is a schematic diagram of a catheter mounting structure of a catheter driver according to an embodiment of the present invention.

Fig. 5 is a schematic structural diagram of coupling a catheter driver and a catheter cartridge according to an embodiment of the present invention.

In the figure:

1: catheter driver

2: catheter tube

3: magnetic field generator

4: main unit

5: computer with a memory for storing data

6: electromagnetic tracking sensor

7: patient(s)

8: multi-joint arm

9: winding drum

10: first outer casing of reel

11: first bevel gear

12: second bevel gear

13: rotating device bracket

14: first gear

15: second gear

16: insertion motor

17: rotary electric machine

18: second housing of winding drum

19: rotary ball bearing

20: insert ball bearing

21: rotating device shell

22: insertion device holder

23: insertion device housing

24: motor casing of insertion device

25: conducting wire

26: tip sensor

27: an opening

Detailed Description

The following describes embodiments of the present invention in detail: the embodiment is implemented on the premise of the technical scheme of the invention, and detailed implementation modes and specific operation processes are given. It should be noted that variations and modifications can be made by those skilled in the art without departing from the spirit of the invention, which falls within the scope of the invention.

The technical scheme provided by the embodiment of the invention is further described in detail below with reference to the accompanying drawings.

and a computer module: for outputting control instructions to the driver.

The above technical solution is described in further detail below with reference to the accompanying drawings in a preferred embodiment.

Please refer to fig. 1 to 5. A preferred embodiment of the present invention provides an in-vivo medical device automatic guidance robot system, comprising:

a catheter driver 1; for driving the insertion of the catheter 2 into the anatomy of the patient 7;

a tracking module; for obtaining the position of the catheter 2 within the anatomy of the patient;

and a computer module: for outputting control instructions to the catheter driver 1.

Further:

the catheter driver 1 may employ a robot configured with 2 degrees of freedom (2 DOF) to automatically insert the catheter 2 into the anatomy of the patient 7.

As shown in fig. 2 to 5, a specific structure of the catheter driver 1 is given. The catheter driver 1 has a compact structure and can drive the catheter 2 to produce two movements: a linear motion and a rotary motion. As shown in fig. 2, the catheter driver 1 comprises a wire 25, which wire 25 connects a tip sensor 26 arranged on the catheter tip and the main unit 4 of the tracking module. The catheter driver 1 further comprises a catheter insertion device, a catheter rotation device, a driver controller and a multi-joint arm 8.

Fig. 3 shows an expanded view of the catheter driver according to fig. 2.

Catheter driver 1:

the catheter insertion device includes: the spool 9, the insertion motor 16, the first gear 14, the second gear 15, the spool first housing 10, the spool second housing 18, the insertion device holder 22, the insertion device housing 23, and the insertion device motor housing 24.

Fig. 4 shows a view of the catheterization apparatus. As shown in fig. 4, catheter 2 is removably coiled on reel 9, and insertion motor 16 is drivingly connected to catheter 2 for driving catheter 2 in a linear direction (forward and backward) for insertion and removal of the catheter into and from the anatomy. For example, the insertion device may insert a catheter into the vascular system as shown in fig. 1. Further, the insertion motor 16 is in driving connection with the spool 9 via the second gear 15 and the first gear 14 in sequence for driving the spool 9 to rotate. When the insertion motor 16 drives the rotation of the spool 9, the catheter 2 is unwound and passed through the opening 27 in the spool first housing 10, thereby inserting the catheter 2 into an anatomical structure, such as the vascular system of a patient. Changing the rotational direction of the spool 9 allows the catheter to be retracted from the anatomy, back into the catheter driver, and the catheter to be rolled onto the spool 9.

The reel 9 and the conduit 2 wound on the reel 9 are enclosed in a first reel housing 10 and a second reel housing 18 to form a detachable reel assembly; the first gear 14 is disposed outside the spool second housing 18; the second gear 15 is meshed with the first gear 14; the first gear, the second gear and the reel assembly are respectively arranged at corresponding positions on the inserting device bracket 22, and a rotary ball bearing 19 is arranged between the reel assembly and the inserting device bracket 22; the insertion device housing 23 is provided outside the insertion device holder 22. The insertion device motor housing 24 is secured to the insertion device bracket 22.

The spool 9 is provided with a helical channel on which the catheter 2 is coiled.

During operation, when the catheter 2 reaches a target location in the anatomy (e.g., the vascular system of a patient), the user may open the reel second housing 18 and remove the catheter 2 from the reel 9; the spool 9 can also be removed from the spool first housing 10 when the spool second housing 18 is removed. After the catheter 2 is detached from the reel 9, the catheter driver 1 may be moved away from the patient 7 while the catheter 2 remains in the patient during the medical procedure (e.g. stent implantation, biopsy, etc.).

The spool assembly is removably mounted on the insertion device holder 22, is integrally removable from the driver holder 2, can be configured as a disposable assembly, and can be preassembled and sterilized.

The catheter 2 is wound on the spool 9 and can be pushed and pulled forward or backward as the spool 9 rotates. The spool 9 is provided with a helical channel on which the conduit is coiled. The spool 9 advances or retracts the catheter 2 disposed on the helical path by imparting a rolling motion so as to minimize friction between the catheter 2 and the opening 27 in the spool first housing 10.

As shown in fig. 5, the catheter rotating device includes: a rotating device bracket 13, a rotating device housing 21 mounted on the rotating device bracket 13, a rotating motor 17, a first bevel gear 11, and a second bevel gear 12; the rotary motor 17 is in driving connection with the first bevel gear 11, and the first bevel gear 11 is meshed with the second bevel gear 12; the second bevel gear 12 is connected to an insertion device holder 22 of the catheter insertion device by an insertion ball bearing 20.

The catheter rotation means can drive the catheter 2 in a rotational movement about the axis of the catheter 2, which is obtained by means of a rotary motor 17, a first bevel gear 11 and a second bevel gear 12. The rotating motor 17 drives the first bevel gear 11 to rotate, the first bevel gear 11 drives the second bevel gear 12 to rotate, and the second bevel gear 12 drives the whole catheter insertion device to rotate, so that the catheter 2 rotates around the axis of the catheter insertion device. The catheter 2 can be rolled on the reel 9 by rotating the entire catheterization apparatus.

The catheter insertion device and the catheter rotation device cooperate to provide the catheter 2 with the required movement, i.e. a combination of translational insertion and rotational movement. Twisting the catheter 2 with a rotational motion as the catheter 2 is advanced within the anatomy (e.g., within the vascular system) may be used to select a particular branch when the catheter tip reaches an intersection of the anatomy (e.g., an intersection in the vascular tree).

The multi-joint arm 8 is provided at the bottom end of the rotating device holder 13 for holding and positioning the catheter insertion device and the catheter rotating device. The multi-joint arm 8 includes: a fixed part for connection to an operating table, and an angularly adjustable fixed part for fixing the catheter insertion device and the catheter rotation device at different angles. The fixing component can be arranged on the base or the side surface of the operating table, and can enter different positions of a patient according to the catheter so as to be fixed on the operating table to facilitate fixing of the multi-joint arm.

The driver controller controls the operation of the insertion motor 16 and the rotation motor 17 according to the instruction of the computer module, and the catheter 2 is driven by the motor to enter the anatomical structure.

The driver controller receives information from the computer module and controls the motor based on the information, thereby controlling the movement of the catheter 2. The drive controller may control the motor through an IEEE/LabVIEW interface.

Catheter 2 may include one or more lumens, a catheter tip disposed at the distal end of the lumen, and a tip sensor 26 disposed at the catheter tip; the catheter tip is capable of guiding the catheter 2 through the anatomy, the tip sensor 26 may be connected to a wire 25 running along the catheter 2, and the tip sensor 26 may be connected to the tracking module by the wire 25. The catheter 2 may be any commercially available flexible instrument and may also include a guidewire with a tracking sensor near the tip of the guidewire. And catheter 2 may also include cameras, probes, guidewires, sensors, multiple lumens, other catheters, tubular flexible medical devices, radio or cryoablation catheters, biopsy needles, forceps, clips, sutures, scissors, scalpels, etc. that are passed through the catheter lumen into the anatomy. The robotic system in the embodiments of the present invention may use multiple types of catheters and is not limited by the type of catheter used.

The configuration of the tracking module depends on the position of the tip sensor 26 disposed at the catheter tip. The tracking module may employ an electromagnetic tracking system, which may include a magnetic field generator 3, a main unit 4, one or more electromagnetic tracking sensors 6 arranged on a patient 7. The electromagnetic tracking sensor 6 forms a tracking mark. A commercial navigation tracking system (e.g., aurora electromagnetic tracking system manufactured by NDI corporation may be employed) may be used, and the methods and apparatus of the present invention are not limited by the type of tracking system and sensor used.

Wherein:

the connection relationship between the magnetic field generator 3, the main unit 4, the one or more electromagnetic tracking sensors 6 is: the magnetic field generator is arranged near the patient; the main unit is connected with an electromagnetic tracking sensor placed at a corresponding position of a patient through a wire; a tip sensor disposed in the catheter is connected to the main unit through a wire; the main unit is connected with the computer through a wire; the functions to be implemented by each component are: magnetic field generator: generating an alternating magnetic field; electromagnetic tracking sensor: the alternating magnetic field generated by the magnetic field generator is induced by utilizing the electromagnetic induction principle, and the data of the induction signals are transmitted to the main unit; a main unit: and receiving the data from the electromagnetic tracking sensor, processing the data, mainly comprising operational amplification, digital-to-analog conversion and the like, transmitting the processed data to a computer module, and calculating specific position information by the computer module.

The computer module includes: the system comprises a medical program planning module, a navigation module, a man-machine interaction module and an imaging module; wherein:

an imaging module for receiving one or more CT and/or MRI images corresponding to an anatomical structure and performing compression processing and receiving one or more tracking marker signals, configured as an image of a three-dimensional map of the anatomical structure, wherein a mapping point of a target position on the map can be represented by a coordinate system established on an electromagnetic tracking sensor;

A medical procedure planning module for identifying a target location on one or more images corresponding to an anatomical structure (e.g., a CT scan of a pre-operative patient);

the navigation module is used for creating a traveling path of the catheter according to the entry point and the target position on the 3D map;

and the man-machine interaction module is used for generating a control instruction for a driver controller of the catheter driver so as to control the motion of the catheter.

Further, the method comprises the steps of,

the medical programming module and navigation module may be implemented with the iMTCEH software package along with CustusX or other available free software libraries (e.g., additional algorithms and mathematical formulas for improving navigation accuracy).

As described above, the in-vivo medical device automatically guides the robot system to realize interaction between the respective components through cooperative work between the plurality of devices and the control module, thereby realizing various actions of the robot system.

Another embodiment of the present invention provides an in-vivo medical device automatic guidance robotic system that differs from the robotic system provided in the above embodiments in that the driver provided is an endoscope driver. The endoscope driver has similar functions and structures as the catheter driver 1 described above, and can be used to drive one or more guide wires, catheters, endoscopes, probes, etc., and the structure and implementation process are similar to those of the catheter driver 1, and will not be repeated here.

It will be appreciated from the above that any flexible instrument may be driven using the actuator arrangements described above, the spool being provided with a helical channel and the flexible instrument may be coiled on (e.g. laid on) the helical channel. As the spool rotates, the flexible instrument is pushed forward or pulled backward, advanced or retracted. The spiral channel design minimizes friction between the flexible instrument and the driver by imparting a rolling motion to advance or retract the instrument.

The automatic guiding robot system for the medical instrument in the body provided by the embodiment of the invention can be used for guiding medical catheters, endoscopes and similar flexible surgical instruments, such as: a guidewire, a radio or cryoablation catheter, a biopsy needle, forceps, clamps, sutures, scissors, scalpels, etc.

The working process of the in-vivo medical device automatic guidance robot system is further described below with reference to several specific application examples, and the medical process involved in the following description process is only used for easier understanding of the implementation steps of the robot system in specific working provided by the embodiment of the present invention, and does not belong to the disease diagnosis and treatment methods.

In one specific application, the automated guided robotic system for in vivo medical devices described above is employed to perform cardiac catheterization. In this case, the user (e.g., a cardiac surgeon or vascular surgeon) will first determine the anatomy (heart or major blood vessel) within the cardiovascular system as the target for stent placement or angioplasty. The anatomy of the sensitive areas of the patient (i.e., the abdomen and chest) will be reconstructed from CT scan images of the patient. Before the operation, the CT scan is performed after the electromagnetic tracking sensor 6 is placed on the chest of the patient. The patient is transferred to the operating room, the electromagnetic tracking sensor 6 is held on the chest, and the tracking module (employing the electromagnetic tracking system ETS) is placed near the patient and connected to the computer module. The surgeon selects a catheter insertion and target point in the CT scan and the navigation module will automatically create a path from the insertion point to the target point. After the path creation is completed, the user will be allowed to visualize the path from the entry point (i.e. femoral artery or vein) to the target (i.e. lesion or atherosclerotic plaque of the abdominal aorta or thoracic aorta or heart).

The catheter insertion device and catheter rotation device are adjusted to the proper position for vascular insertion by the multi-jointed arm 8 by mounting the pre-assembled reel assembly on the insertion device holder 22 and securing the catheter driver 1 to the patient table and connecting the catheter-attached guide wire 25 to the tracking module.

From the complete winding of the catheter 2 on the reel 9, the operator can manually unwind the catheter 2 from the reel 9 to allow the surgeon to insert the catheter tip into the patient's blood vessel in accordance with classical medical procedures. The computer module uses the electromagnetic tracking sensor 6 for automatic registration between the CT data and the patient, by performing a comparison in virtual 3D space, finding a position of the reference sensor similar to the position of the real sensor in real space.

In this particular application, the robotic system, unlike the current state-of-the-art systems, allows the operator to select one of three different modes of use: manual, semi-automatic, and fully automatic. In either mode, the user uses the navigation module of the computer module, in conjunction with the tracking module, to implement an Electromagnetic (EM) navigation procedure to advance a medical instrument (e.g., a guide wire equipped catheter, medical forceps, or other interventional instrument) to a target location. Currently, vascular medical robots are guided only manually by a joystick, which, while manual control may reduce or eliminate operator exposure to radiation, is not possible for the patient. In contrast, the semi-automatic and fully automatic modes disclosed in this particular application example almost completely eliminate exposure of the patient or operator to harmful radiation. The robotic system disclosed in this particular application example may orient the medical instrument to a target location and perform a biopsy or other medical procedure while the catheter remains in place, making the procedure more accurate.

The position of the catheter tip relative to the patient is continuously provided to the software by the electromagnetic tracking system ETS and the tip sensor 26. Thus, the robotic system can at any time ensure that the catheter tip is in the correct path.

With the electromagnetic tracking system ETS and navigation module, the robotic system can move the catheter over a planned path to accurately reach the target without performing an X-ray scan during catheterization. When encountering a branch of anatomy (e.g., a vessel branch), the robotic system may select a particular vessel branch by a combined motion of rotating, inserting, and retracting the catheter until the catheter tip is aligned in the correct direction and advanced toward the desired branch. After reaching the target location and confirming, the spool second housing 18 may be opened and the catheter may be separated from the catheter driver. The tip sensor 26 may be retracted from the working channel of the catheter and another instrument may be inserted through the catheter, such as a biopsy needle for standard biopsy acquisition or an endoscopic probe for acquiring imaging data.

In another specific application example, the robotic system may be used to navigate to a lesion in the lung for diagnosis and treatment of early stage lung cancer. In this case, the anatomical object appears as a small (< 1 mm) suspicious lesion located around the lung that is not reachable by normal bronchoscopy. Similar to cardiovascular applications, after reconstruction of patient anatomy from diagnostic CT scans, entry points (i.e., the trachea or main lung airways) and targets (i.e., suspicious lung lesions detected in CT examinations) are defined in a virtual 3D model of patient anatomy. The robotic system will guide the catheter and various medical instruments from the entry point to the target under the guidance of the navigation module. Several ways of implementing the operation of the robotic system are described below.

Method 1 (automatic mode): a method of performing a medical procedure on a patient anatomy using the robotic system described above. The method may include attaching tracking markers of the tracking module to the patient's body and performing CT/MRI imaging of the patient, such as capturing anatomical structures and markers. The method may further comprise rendering a 3D model of the anatomical structure (e.g. in a reference frame attached to the marker), and then loading said 3D model onto a computer.

The method may further include creating, via a navigation module of the computer module, an access path (e.g., via an artery, a trachea, an esophagus, etc.) and a target point on the 3D model or anatomical structure. The method may include inserting a catheter at a point on the body corresponding to the entry point or the access path and directing the catheter on the access path toward the target point.

Guiding the catheter towards the target point may comprise the steps of receiving information from the tracking tip sensor via the navigation system, and calculating the position of the tip sensor on the access path. Step 2 includes calculating a desired path (e.g., a 2mm long path) along which the catheter is moved from the current location to the target point. Step 3 includes calculating a set of motor movements, insertion movements and rotational movements corresponding to moving the catheter in the desired path. Step 4 includes sending, by the driver controller, a set of signals to the motor corresponding to the motor motion. The above steps are then repeated until the catheter reaches the target point.

Once the edge of the catheter reaches the target point, the catheter driver is disconnected from the catheter and the tracking sensor can be removed.

Method 2 (semi-automatic mode): a method of performing a medical procedure on a patient anatomy using the robotic system described above is disclosed. The method comprises attaching an electromagnetic tracking sensor 6 of a tracking module to the patient's body and performing a CT/MRI scan on the patient. The method may further comprise rendering a 3D model of the anatomical structure in a reference frame attached to the marker, and then loading said 3D model onto a computer.

The method further includes calculating, via a computer, a target point on the 3D model of the access path (e.g., via an artery, trachea, esophagus, etc.) and the anatomical structure. The method may further include inserting a catheter at a point on the body corresponding to the entry point of the access path and directing the catheter on the access path toward the target point.

The guiding of the catheter towards the target point may comprise the following steps. Step 1 includes receiving information from the tip sensor via a navigation module and calculating a current position of the tip sensor on the access path. Step 2 comprises defining a desired path portion (e.g. a 2mm long path) along which the catheter is moved from the current position to the target point. Step 3 includes directing the drive motor through a computer interface, which is shown on the display as including up/down arrows for advancing/retracting the catheter and left/right arrows for rotating the catheter left/right. Step 3 may also include guiding the driver motor through a joystick to enable an operator to manually control the catheter to move in a desired path. The above steps are then repeated until the catheter tip reaches the target point. Once the catheter tip reaches the target point, the catheter driver may be disconnected from the catheter and the tracking sensor may be removed. Method 3 (manual mode, using conventional fluoroscopy or camera or bronchoscope/endoscope): in this particular application, the robotic system terminates the method of a medical procedure on an anatomical structure or patient. The method may include attaching tracking markers or navigation systems to the patient's body and performing CT/MRI imaging of the patient, such as capturing anatomical structures and markers. The method may further comprise rendering a 3D model of the anatomical structure (e.g. in a reference frame attached to the marker), and then loading said 3D model onto a computer.

The method may further include creating, via the computer module, an access path for the anatomical structure (e.g., via an artery, a trachea, an esophagus, etc.) and a target point on the 3D model. The method may further include inserting a catheter at a point on the body corresponding to the entry point or the access path and directing the catheter on the access path toward the target point.

Guiding the catheter towards the target point may comprise steps 1 and 2 described below. Step 1 receives the current position of the catheter by conventional imaging means (i.e. fluoroscopy or bronchoscope/endoscopic camera). Step 2 includes controlling the motor of the drive through a computer interface, which interface is shown on a computer display, which may include up/down arrows for advancing/retracting the catheter and left/right arrows for rotating the catheter left/right. Step 2 may also include controlling the actuator motor via a joystick to enable an operator to manually control movement of the catheter on a desired path. The above steps are then repeated until the catheter tip reaches the target point. Once the catheter tip reaches the target point, the catheter driver may be disconnected from the catheter and the electromagnetic tracking sensor may be removed.

The automatic guiding robot system and the automatic guiding method for the in-vivo medical instrument provided by the embodiment of the invention can be customized according to the illness state and the requirement of a patient. The robot system can be applied to: a robotic system for automatically guiding the biopsy catheter to a surrounding lung airway target; a robotic system for guiding the catheter during catheterization of the heart; a robotic system for guiding the catheter during gastroduodenal examination; a robotic system for endovascular surgery; a robotic system for guiding a colonoscope or a colonoscope-based medical instrument during colonoscopy, etc.

It will be appreciated by those skilled in the art that the robotic system and method of automatic guidance thereof provided by the above-described embodiments of the present invention may include various types of components that perform various types of functions, such as various types of guidewires and catheters may be used, for example, specifically designed for: endoscopy, bronchoscopy, colonoscopy, cardiac catheterization, and guidewires and catheters. Various types of endoscopes may be used for different applications, such as: gastrointestinal tract (esophagus, stomach and duodenum), small intestine (enteroscope), large intestine/colon (enteroscope, sigmoidoscope), bile duct, rectum (rectoscope) and anus (anoscope); the respiratory tract: nose (rhinoscope), lower segment respiratory tract (bronchoscope); ear: otoscope (otoscope); urinary tract: cystoscope; female genital tract (gynecological mirror): cervical (colposcope), uterine (hysteroscope), oviduct (oviduct lens); through a small incision: abdominal or pelvic (laparoscope), internal joints (arthroscope), organs or chest (thoracoscope and mediastinoscope).

Various types of catheter tips may be used, for example: straight, curved or partially curved tips. Various types of tip sensors may be used, including: any one or more of a probe, a sensor, and an electrode may be used, for example: force sensitive sensors, cameras, LEDs, electrodes, piezoelectric sensors, fluid or gas pressure sensors.

The automatic guiding robot system and the automatic guiding method for the medical equipment in the body, provided by the embodiment of the invention, obviously reduce the X-ray irradiation of patients and doctors; minimizing friction between the flexible instrument and the robotic component; the overall size of the robotic system is reduced; the production cost is reduced; and shortens the duration of the clinical procedure. A combination of medical procedures can be achieved, such as a combination of bronchoscopy joint diagnosis (i.e., via tissue biopsy) and open laparoscopic surgical treatment (i.e., tissue ablation or ablation). The robotic system may also be provided with special instruments manipulated by the intelligent robotic system, electromagnetic tracking systems, and laparoscopic instruments with optical and electromagnetic tracking capabilities.

The automatic guidance robot system for in-vivo medical instruments and the automatic guidance method thereof provided by the embodiment of the invention can be used for executing the following steps: three-dimensional anatomy models for CT or MRI scanning, difficult anatomy, and surgical planning of small peripheral objects, while performing Electromagnetic (EM) and optical navigation for single or multiple instrument guidance to improve accuracy.

The in-vivo medical instrument automatic guiding robot system and the automatic guiding method thereof provided by the embodiment of the invention are used for realizing the method of the robot system for automatically guiding the medical instrument into an anatomical structure in various medical procedures. A motor-controlled insertion device and rotation device are provided to combine insertion and rotation of the flexible instrument to rotationally advance the flexible instrument upon entry into the anatomy. The tracking module determines the location in the anatomy by a tracking sensor placed at the tip of the flexible instrument. The movement of the flexible instrument is driven by a motor controlled by a controller by which the flexible instrument is moved into position in the anatomy to be positioned by the tracking sensor. The method and the system can obviously reduce the x-ray exposure of patients and doctors, reduce the friction between flexible instruments and robot parts, reduce the size of the robot system, reduce the production cost and reduce the time of clinical treatment.

Although only a few embodiments have been described in detail above, those skilled in the art will appreciate that many changes can be made from the described embodiments without departing from the spirit of the invention. The invention has been described with a schematic illustration of idealized embodiments (and intermediate structures). Therefore, the shape of the illustration changes due to manufacturing techniques, errors, and the like. Thus, embodiments of the invention should not be construed as limited to the particular shapes of regions illustrated herein but are to include deviations in shapes that result, for example, from manufacturing techniques.

The in-vivo medical device automatic guidance robot system and the automatic guidance method thereof provided by the above-described embodiments of the present invention may include an alternative or additional device/step added based on the need. It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit, scope or invention. It is therefore intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the invention or the appended claims and their equivalents.

Claims

1. An in-vivo medical device automatic guidance robotic system, comprising:

and a computer module: for outputting a control instruction to the driver; the driver comprises a wire, an inserting device, a rotating device, a driver controller and a multi-joint arm; wherein:

the multi-joint arm is used for supporting and fixing the inserting device and the rotating device; the insertion device includes: the device comprises a winding drum, an inserting motor, a first gear, a second gear, a winding drum first shell, a winding drum second shell, an inserting device bracket and an inserting device shell; wherein:

The reel and the flexible instrument are packaged in a first reel housing and a second reel housing to form a detachable reel assembly; the first gear is arranged on the outer side of the second shell of the winding drum; the second gear is meshed with the first gear; the first gear, the second gear and the reel assembly are respectively arranged at corresponding positions on the insertion device bracket, and a rotary ball bearing is arranged between the reel assembly and the insertion device bracket; the insertion device shell is arranged on the outer side of the insertion device bracket; the winding drum is provided with a spiral channel, and the flexible instrument is coiled on the spiral channel; the rotating device includes: a rotating device bracket, a rotating motor mounted on the rotating device bracket, a first bevel gear and a second bevel gear; the rotary motor is in driving connection with a first bevel gear, and the first bevel gear is meshed with a second bevel gear; the second bevel gear is connected with an inserting device bracket of the inserting device through an inserting ball bearing;

the rotating motor drives the first bevel gear to rotate, the first bevel gear drives the second bevel gear to rotate, and the second bevel gear drives the whole inserting device to rotate, so that the flexible instrument is driven to do rotary motion around the axis of the flexible instrument; the multi-joint arm sets up in rotary device's rotary device support's bottom, includes: a fixing part for connecting to the operating table, and an angle-adjustable fixing part for fixing the insertion device and the rotation device at different angles; the driver controller controls the insertion motor of the insertion device and the rotating motor of the rotating device to work according to the instruction of the computer module, and the linear motion and the rotating motion of the flexible instrument entering the anatomical structure are realized under the driving of the motor; the driver controller receives information from the computer module and controls the motor based on the information to control movement of the flexible instrument; and/or the driver controller controls the motor through an IEEE/LabVIEW interface; the flexible instrument comprises one or more lumens, an instrument tip disposed at the distal end of the lumen, and a tip sensor disposed at the instrument tip; the instrument tip guides the flexible instrument through the anatomy, the tip sensor is connected to a lead running along the flexible instrument, the tip sensor is connected to the tracking module by the lead;

The tracking module adopts an electromagnetic tracking system and comprises a magnetic field generator, a main unit and one or more electromagnetic tracking sensors; the magnetic field generator is arranged in the vicinity of the patient; the main unit is connected with an electromagnetic tracking sensor placed at a corresponding position of a patient through a wire; the tip sensor is connected with the main unit through a wire; the main unit is connected with the computer module through a wire; wherein:

the position of the tip sensor is determined by a coordinate system arranged on an electromagnetic tracking sensor, and the electromagnetic tracking sensor forms a tracking mark;